Inspections, Compliance, Enforcement, and Criminal Investigations
Syncor International Corporation 05-Sep-01
DEPARTMENT OF HEALTH AND HUMAN SERVICESouthwest Region
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
September 5, 2001
CERTIFIED MAIL RETURN RECEIPT REQUESTED
Ref. # DEN- 01-48
Mr. Robert G. Funari
Syncor International Corporation
6464 Canoga Ave.
Woodland Hills, CA 91367
Dear Mr. Funari:
During an inspection of your pharmaceutical manufacturing facility, located at 1313 Washington Ave., Golden, Colorado, conducted from July 13 through 23, 2001, Investigator Karen G. Hirshfield documented significant deviations from Current Good Manufacturing Practices (cGMPs) for Finished Pharmaceuticals (Title 21, Code of Federal Regulations, Parts 210 and 211). These deviations cause your drug products to be adulterated within the meaning of Section 501 (a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). The deviations include, but are not limited to, the following:
1. Failure to have or to follow written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess as required by 21 CFR 211.100. For example, SOP No. [redacted] (Calibration [redacted] requires that one [redacted] source be assayed over 96 hours for the [redacted]. Test, however, during the inspection it was found that two sources of [redacted] were being used and assayed for only 48 hours.
2. Failure of Master production and control records to include complete manufacturing and control instructions, sampling and testing procedures, specifications, special notations and precautions to be followed as required by 21 CFR 211. 186(b)(9). For example, the master production and control record for Sodium Iodide 1-123 Capsules does not reference all analytical tests that are performed including the x samples analyzed to calculate the conversion factor from the [redacted] or the [redacted] samples used to determine [redacted] limits.
3. Failure of the quality control unit to assure that all unexplained discrepancies or failures of batches to meet specifications are thoroughly investigated and that the records of the investigations are complete, including conclusions and follow-ups as required by 21 CFR 211.192. For example, a Corrective and Preventative Action Report (CaPAR) was not generated for the wrong calibration dates assigned to lot [redacted] as required by [redacted] (Corrective and Preventive Action). In addition, CaPARs are not documented until all of the information is complete, which maybe months after the nonconformances or deficiencies are identified.
4. Failure to follow written procedures designed to assure that correct labels, labeling, and packaging materials are used for drug products as required by 21 CFR 211.130. For example, misprinted labels were issued for Batch No. [redacted] and Batch No. [redacted] despite being reviewed for accuracy by at least two individuals.
5. Failure to maintain complete records of the periodic calibration of instruments, apparatus and gauges as required by 21 CFR 211. 194(d). For example, [redacted] and [redacted] were not always recorded for the [redacted] semi-annual calibration tests in accordance with SOP No. [redacted].
The above list of violations, as well as the Form FDA-483, List of Observations, issued at the conclusion of the inspection to Mr. Michael J. Schwimmer, General Manager, is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure adherence with the requirements of current Good Manufacturing Practice Regulations. Federal agencies are advised of the issuance of all warning letters so that they may take this information into account when considering the award of contracts. A copy of the Form FDA-483, List of Observations, is enclosed.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action, including seizure or injunction, without further notice.
We acknowledge receipt of Ms. Kae D, Miller?s response to the FDA-483, dated August 14, 2001. Ms. Miller?s response states that corrections to each observation on the FDA-483 are being implemented although specific timeframes for the corrections are not always included, We would like to point out that following our previous inspection of this facility in March 1998, we also received a response promising corrections to each observation on the FDA-483. An untitled letter from this office, dated July 14, 1998, acknowledged your firm?s response letter, stating in part, "While we found Mr. Coggan?s response to be adequate, be advised that we found significant deviations from Current Good Manufacturing Practice . . ..". A copy of the July 14, 1998 letter is enclosed for your information. We are concerned to find continuing deviations. When implementing corrections to the observed deviations, your corrective action should address the deficiencies at the system level to ensure similar deficiencies are also addressed.
Please advise this office in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have or will take to prevent the recurrence of similar violations. 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 response should be directed to H. Tom Warwick, Compliance Officer, at the above address.Sincerely,
Thomas A. Allison