|Company:||Oklahoma Respiratory Care, Inc.|
|Subject:||CGMP for Finished Pharmaceuticals/Adulterated|
|Issuer:||Dallas District Office|
|Issued:||June 18, 2012||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
June 18, 2012
RETURN RECEIPT REQUESTED
Mr. Thayne Kevin Barnes
Oklahoma Respiratory Care, Inc.
623 N. Porter Ave.
Norman, Oklahoma 73071
Dear Mr. Barnes:
During our October 19-28, 2011 inspection of your pharmaceutical manufacturing facility, Oklahoma Respiratory Care, Inc., located at 1010 N. University Blvd., Norman, Oklahoma 73069, an investigator from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug product(s) to be adulterated within the meaning of section 501 (a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351 (a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.
Specific violations observed during the inspection include, but are not limited to, the following:
1. Your firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release [21 C.F.R. § 211.165(a)].
For example, your firm's (b)(4) transfill employees, who have worked at your firm since January 2011, and May 2011, respectively, and are responsible for transfilling oxygen USP, stated that they had not performed identity or purity testing on incoming oxygen or finished products. In addition, they told the investigator that they had not received training on how to use the oxygen analyzer or how to perform purity and identity testing on finished drug products. However, they documented on batch records that the final testing had been completed. Your firm was unable to determine when purity and identity testing had last been completed for your drug products.
2. Your quality control unit (QCU) failed to review and approve all production and control records to determine compliance with all established, approved written procedures before releasing and distributing a batch [21 C.F.R. § 211.192].
For example, your SOP 5-19 "FDA COMPLIANCE," approved April 4, 2006, states that the QCU duties include approving or rejecting any drug products and reviewing production records to assure that no errors have occurred. However, from January 1, 2011, through October 18, 2011, the employee responsible for the review failed to verify that your firm conducted identity and purity testing for 59 lots of Oxygen, USP. Also, during the inspection, our investigator reviewed batch records from 2003 to present. All of these records lacked documentation of purity testing. Furthermore, your QCU employee told the investigator that he never reviewed batch records to ensure that test results confirmed that the products met their required specifications prior to release.
Batch records are critical records and it is your responsibility to ensure that all production and control records are accurate, complete, authentic, and produced concurrently with the documented activity, and that employees are appropriately trained. Please explain how your firm will ensure compliance with the regulations. Also, provide a copy of your investigation into your failure to review the records, including the potential impact it had on product in distribution.
3. Your firm has failed to bear an expiration date determined by appropriate stability testing, described in 21 C.F.R. § 211.166, for your repackaged drug products to assure that they meet applicable standards of identity, strength, quality, and purity at the time of use [21 C.F.R. § 211.137(a)].
For example, your firm used a 5 year expiration date on the transfilled Oxygen, USP without having conducted a stability study for this drug product to justify the expiration date.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure compliance with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. Other federal agencies may take this warning letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending drug applications listing your facility, until the above violations are corrected. FDA may re-inspect to verify corrective actions have been completed.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. Additionally, your response should state if you no longer manufacture or distribute Oxygen, USP, and provide the date(s) and reason(s) you ceased production.
Your response should be sent to the Food and Drug Administration, Dallas District Officer, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204, to the attention of Elvia J. Cervantes, Compliance Officer. Should you have any questions concerning this letter, you can contact Elvia Cervantes at (214) 253-5236.
Reynaldo R. Rodriguez, Jr.
Dallas District Director
cc: Paul R. Oldfather, Patient Care Coordinator
Oklahoma Respiratory Care, Inc.
1010 N. University Blvd.
Norman, Oklahoma 73069