|Company:||Shah Distributors, Inc.|
|Subject:||CGMP Regulation For Food/Adulterated|
|Issuer:||Los Angeles District Office|
|Issued:||July 15, 2010||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
RETURN RECEIPT REQUESTED
July 15, 2010
Anas A. Shah, President and Owner
Shah Distributors, Inc
540 Patrice Place
Gardena, CA 90248-4232
Dear Mr. Shah:
The Food and Drug Administration (FDA) conducted an inspection of your facility, located at 540 Patrice Place, Gardena, California, on February 8, 11, 16, 17, 18, 23,24,25, and March 1 and 4, 2010. During the inspection, FDA investigators documented significant violations of the Current Good Manufacturing Practice (CGMP) regulations for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These violations cause the foods stored and processed at your facility to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth. You can find links to the Act and regulations at FDA's website at www.fda.gov .
The violations identified by our investigators were documented on the Form FDA 483, Inspectional Observations, issued to your firm on March 4, 2010. Specifically:
1. Failure to take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests [21 CFR 110.35(c)]. Rodent, bird, and insect activity were observed along all four walls of the warehouse, in and around the repackaging area, and along both the, north and south sides of the southernmost interior shelving unit.
As a result of the substantial pest activity within your facility, public health officials took steps to prevent distribution of products from the facility. During the course of the inspection, officials from FDA, in collaboration with the Los Angeles County Department of Public Health (LACDPH), witnessed the destruction of approximately 43 tons of food products that were condemned by the LACDPH. We also acknowledge the voluntary destruction of approximately 30 tons of other products.
2. Failure to maintain equipment and utensils in an acceptable condition through appropriate cleaning and sanitizing [21 CFR 110.80(b)(1)].
a. The weigh/fill machine used to package food is not cleaned after the packaging of each different type of food product.
b. A cashew was observed at the bottom of the weigh/fill machine hopper, and spices and unidentified food residue were observed covering the hopper and exit chute of the weigh/fill machine.
3. Proper precautions to reduce the potential for contamination of food, food-contact surfaces, and food-packaging materials with microorganisms and filth cannot be taken because of deficiencies in plant construction and design [21CFR 110.20(b)(2)].
a. There were no physical barriers between the repackaging area and the rest of the warehouse. There is no door, and the walls of the repackaging area do not extend to the ceiling.
b. The walls of the southeast comer of the repackaging room had exposed drywall joint tape and a 1/2 inch gap along the entire length of the comer of the walls.
4. Failure to maintain buildings and physical facilities in repair sufficient to prevent food from becoming adulterated [21 CFR 110.35(a)]. Holes/gaps in walls were observed in the warehouse and in the repackaging area:
a. On the south wall of the room in the northeast comer of the warehouse, a hole approximately 8-inches by 12-inches was observed about 2 feet above the ground.
b. A gap of approximately 1/2 inch was observed between the east wall and the floor of the repackaging room. In addition, a hole approximately 1-inch high by 2-inches wide was located directly above the gap, leading to the warehouse area on the other side of the wall. A second hole, approximately 1/2 inch high by 2-inches wide was located to the left of the above hole.
c. Two damaged areas with holes were observed on the back of the east wall of the repackaging area. The holes were about 2 inches apart, located directly above the floor, and measured approximately 1-inch by 3-inches and 2-inches high by 8-inches wide.
5. Failure to provide adequate screening or other protection against pests [21 CFR 110.20(b)(7)].
a. A 5-inch gap was observed in the mesh wire surrounding the two freezer containers adjacent to the warehouse. In addition, the 1-inch openings in the mesh provide potential pest entry.
b. On the roll-up door of the entrance to the warehouse on the north wall, several of the hanging plastic strip curtains were missing or tom, leaving at least three approximate 1-foot openings from the warehouse directly to the exterior.
6. Failure to provide employees with adequate toilet facilities [21 CFR 110.37(d)].
a. An 8-inch by 12-inch hole was present in south area of the ceiling of the toilet room, exposing the wood flanks underneath.
b. The ceiling air vent in the toilet room was covered with what appeared to be grime and hair.
7. Failure to provide safety-type light bulbs suspended over exposed food [21 CFR 110.20(b)(5)]. The fluorescent lighting strip above the repackaging area and repackaging machine was uncovered or otherwise unprotected from breakage.
8. Failure to provide adequate hand-washing facilities [21 CFR 110.37(e)]. There was no sign directing employees to wash their hands posted throughout the duration of the inspection.
We acknowledge that you promised certain corrective actions during the inspection, including implementing a new pest control program, cleaning, removing debris, repairing walls, and altering the repackaging room so that its walls and ceiling are complete.
This letter is not intended to be an all-inclusive list of the violations at your facility or regarding your products. It is your responsibility to ensure compliance with the Act and with the regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483, issued at the closeout of the inspection may be symptomatic of serious problems in your firm's facility. You should investigate and determine the causes of the violations and take prompt action to correct the violations. Failure to promptly correct these violations may result in legal action without further notice including seizure and injunction.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your written response should be sent to:
U.S. Food and Drug Administration
Attn: Dan Solis
Director, Imports Operations Branch
Los Angeles District
222 W. 6th Street, Suite 700
San Pedro, CA 90731
If you have any questions about the content of this letter please contact Ryan Borges, Compliance Officer, at 310-971-2287.
Alonza E. Cruse
Los Angeles District Director