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FDA establishment 3011320041, Palm Harbor, Florida, United States. Part of Regenerative Processing Plant's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 4
Official action indicated: 1
Last inspection ended: Jun 30, 2023
Warning letters: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.160(b)(1). Samples (various types) representative, identified properly Samples taken to determine conformance to appropriate written specifications for the acceptance of each lot within each shipment of drug product containers are not representative.
21 CFR 211.170(b)(1). Retention time of reserve samples, in general You did not retain reserve samples for drug products for one year after the expiration dates of the drug products.
21 CFR 211.188(b)(3). Identification of each component or in-process material Batch production and control records do not include the specific identification of each batch of component used for each batch of drug product produced.
21 CFR 211.194(a)(4). Complete Test Data Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
21 CFR 211.94(b). Protection from external factors Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
21 CFR 211.84(d)(2). Component identification test Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.
21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the process.
21 CFR 211.42(a). Buildings of Suitable Size, Construction, Location Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable to facilitate cleaning, maintenance, and proper operations.
21 CFR 211.180(b). Record maintenance 1 year (except exempt OTC) All records of production associated with a batch of drug product were not maintained at least one (1) year after the expiration date.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.166(a). Results not used for expiration dates, storage cond. Results of stability testing are not used in determining appropriate storage conditions and expiration dates.
21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Official Action Indicated (OAI)
Dec 12, 2019
Biologics · Human Cellular, Tissue, and Gene Therapies
None posted
No Action Indicated (NAI)
Aug 14, 2017
Biologics · Human Cellular, Tissue, and Gene Therapies
None posted
No Action Indicated (NAI)
Aug 31, 2015
Biologics · Human Cellular, Tissue, and Gene Therapies
None posted
No Action Indicated (NAI)
Warning Letters
Letters naming this establishment; each opens the letter
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Palm Harbor, Florida, United States. Part of