Inspections, Compliance, Enforcement, and Criminal Investigations
Aquarium Products 03-May-06
Department of Health and Human Services
Public Health Service
Baltimore District Office
May 3, 2006
RETURN RECEIPT REQUESTED
Mr. Timothy R. Evans
Executive Vice President
180 Penrod Court, Suite H
Glen Burnie, MD 21061
Dear Mr. Evans:
An investigation of your operation, Aquarium Products located in Glen Burnie, MD on January 5-18, 2006, conducted by a representative of the U.S. Food and Drug Administration, determined that your establishment manufactures drugs as defined by section 201(g) [21 U.S.C. § 321(g)] of the Federal Food, Drug, and Cosmetic Act (the Act).
The investigation revealed that these drugs are adulterated within the meaning of section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B] of the Act in that the methods used in, or the facilities or controls used for the manufacturing, processing, packing, or holding of these drugs are not in conformance with the Current Good Manufacturing Practice (CGMP) regulations as specified in Title 21, Code of Federal Regulations (CFR), Parts 210 and 211. At the close of the inspection, you were issued a form FDA-483, which delineated a number of significant cGMP deviations, including, but not limited to, the following:
1. Failure to test non-penicillin drug products for the presence of penicillin when there is a reasonable possibility that the non-penicillin drug product had been exposed to penicillin. For example, Gel-Tek Penicillin is manufactured using non-dedicated equipment, but non-penicillin products subsequently manufactured using the same equipment are not tested for the presence of penicillin. [21 CFR 211.176]
2. Failure to include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release. For example, there is no documentation that the Gel-Tek Penicillin (batch 5121) that was manufactured on November 2, 2005, was tested to confirm identity and strength prior to release. [21 CFR 211.165(a)]
3. Drug products were formulated with the intent to provide less then 100 percent of the labeled amount of the active ingredient. [21 CFR 211.101(a)]
4. Failure of the label of your drug products to bear an expiration date determined by appropriate stability testing described in 21 CFR 211 .166. For example, the stability program established for Gel-Tek Penicillin only included accelerated studies and does not include full shelf life studies. In addition, the accelerated studies that were conducted on Gel-Tek Penicillin only included visual examination for a change in appearance of the drug product, no reliable, meaningful, and specific test method was utilized to determine the stability characteristics of the Gel-Tek Penicillin drug product. [21 CFR 211.166 & 211.137]
5. Failure to establish procedures for the cleaning and maintenance of equipment used in the manufacture, processing, packing or holding of drug products and failure to maintain the records of these operations at your firm. For example, Gel-Tek Penicillin was manufactured on filling machine #3 on November 7 and 8, 2005, but there is no record that this equipment was cleaned prior to using the equipment to package Gel-Tek Ampicillin on November 16 and 17, 2005. [21 CFR 211.67(b)]
6. Failure to establish and 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. For example, you have not validated the manufacturing process for any of your drug products. [21 CFR 211.100 & 211.110]
7. Failure to establish and follow procedures that describe the in-process controls, test, and examinations to be conducted on appropriate samples of in-process materials of each batch of drug product. For example, there is no procedure for the in-process testing performed on the Gel-Tek Penicillin and tetracycline drug products, including any testing to ensure the homogeneity of the finished drug product. [21 CFR 211.110(a)]
8. Failure to establish written procedures which describe in sufficient detail the identification, sampling, and testing of components, drug product containers, and closures prior to releasing them for use in the manufacturing, processing, and packaging of any of the finished drug products. [21 CFR 211.80(a) & 211.84(a)]
9. All of the CGMP deficiencies are indicative of your Quality Control Unit's failure to meet requirements impacting the identity, strength, quality, and purity of your drug products [21 CFR 211.22].
We are in receipt of your written response to the Form FDA-483 issued at the close of the inspection. Your response does not contain sufficient information for an adequate review of all of your planned or completed corrective action. Please provide the policies, procedures, test methods and other supporting documentation referenced in your response.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that your firm's operations and the drug products it distributes comply with the law. You should take prompt action to correct these deviations. Failure to promptly correct these violations may result in regulatory action without further notice. Such actions include, but are not limited to, seizure and/or injunction. In addition, Federal Agencies are advised of the issuance of all Warning Letters about drugs and devices so they may take this information into account when considering the award of contracts.
Please notify this office in writing, within 15 working days of receiving this letter, of the specific steps you have taken to correct the noted violations and to prevent their recurrence. You should include in your response documentation and written verification procedures or other useful information that would assist us in evaluating your corrections. If the corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your reply should be sent to the Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215, Attention: Steven B. Barber, Compliance Officer. If you have any questions concerning this letter, you may contact Mr. Barber at 410-779-5134.
Acting District Director