Inspections, Compliance, Enforcement, and Criminal Investigations
Absolute Packaging Inc 15-Dec-03
Department of Health and Human Services
Public Health Service
555 Winderley Place Ste 200
RETURN RECEIPT REQUESTED
December 15, 2003
Glen R. Warner, President
Absolute Packaging, Inc.
320 Stan Drive, Suite A
Melbourne, Florida 32904
Dear Mr. Warner:
During an inspection of your facility on May 27 - June 3, 2003, FDA Investigators Holly Scott and Salvatore Randazzo determined your firm manufactures over the counter (OTC) topical preparations including sunscreen and bath products. Skin protectant products containing sunscreens are drugs within the meaning of section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act), since these products contain representations in their labeling that suggest that these products affect the structure or function of the body in man.
The inspection revealed that these drugs are adulterated within the meaning of section 501(a)(2)(B) of the Act in that they are drug products and 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 current good manufacturing practice (GMP) regulations for drugs specified in Title 21, Code of Federal Regulations (CFR), Part 211. The deficiencies included, but were not limited to:
Components with certificates of analysis from the component suppliers are not periodically tested for all required component specifications to verify the reliability of certificate of analysis results, nor are any specific identity tests performed on components. 21 CFR 211.84;
Appropriate stability studies have not been for performed for several of your sunscreen products, nor is there a written testing program designed to assess the stability characteristics of these products. 21 CFR 211.166;
There is no quality control unit, nor are there procedures outlining the approval or rejection of components, in-process materials or finished products, or the review of production records. 21 CFR 211.22;
There is no documentation that master production and control records for each batch size are prepared and signed by one individual and independently checked and verified by a second qualified individual. 21 CFR 211.186;
There is no validation of the manufacturing processes, nor have control procedures been established that describe in-process controls, tests, or examinations to on be performed appropriate samples, or to monitor the output of those manufacturing processes to assure that drug products produced have the identity, strength, quality and purity they purport to posses. 21 CFR 211.100 & 110;
Batch control records are incomplete in that they lack statements or calculations of and actual theoretical yield, identification of each batch of component or in-process material, sampling performed and in-process or laboratory control results, specimen or copies of all labeling used, and identification or initials of persons performing or supervising each significant step in the manufacturing process. 21 CFR 211.188;
Written procedures for equipment cleaning and maintenance do not exist, nor have the cleaning procedures in use been properly validated. 21 CFR 211.67;
There are no label controls, nor there are any written procedures designed to assure that correct labels and labeling are used or accounted for, and that excess labeling bearing lot or control numbers are destroyed. 21 CFR 211.122 & 125; and,
Neither the employees engaged in the manufacturing operations nor the individuals responsible for supervising the manufacturing processes have been given training in current good manufacturing practice. 21 CFR 211.25.
These deviations from the GMP regulations are similar and, in some cases, identical to those observed during an inspection of your firm in May 2001. At the close of that inspection, and by letter dated June 11, 2001, you promised correction of all deviations; yet these deviations continue to exist.
We have received your letter dated May 29, 2003, in which you state that are you going to stop producing all sunscreen products; however, you also ask for a 4 to 6 month extension during which you intend to continue manufacturing these products. Please be advised that we consider all sunscreen products manufactured under these conditions to be adulterated and subject to regulatory action by the FDA. Also, be advised that once you cease manufacturing sunscreen products, should you wish to begin manufacturing these products at any time in the future, you will be expected to manufacture them in accordance with the GMP regulations.
We received a second letter dated August 5, 2003, stating that while some corrections have been made, others have yet to be implemented, and some, including process validation, master records, and label controls are not addressed. We also have received your letter dated November 7, 2003, in which you acknowledge that have you not sold the sunscreen portion of your business, but instead explain that you intended to "outsource the blending and filling of all sunscreens" to your former consultant. It appears from this explanation that you would still retain control over the sunscreen portion of your business. Meanwhile, your firm continues to manufacture and distribute these violative OTC drug products.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It remains your responsibility to ensure adherence to all requirements of the Act and regulations. You should take prompt action to correct these violations. Failure to correct these violations may result in regulatory action, including seizure and/or injunction, without further notice.
Please notify this office in writing written fifteen (15)working days of receipt of this letter, of the specific steps you have taken to correct these violations add to prevent the recurrence of similar violations. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time within which corrections will be completed. In addition, please inform us of the exact nature of your proposed transaction with your former consultant, and whether it is your intention to sell the drug manufacturing portion of your business.
Your reply should be directed to Martin E. Katz, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida, 32751, telephone (407) 475-4729.
Emma R. Singleton
Director, Florida District