1Laboratory and QC controls
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence ofdeterioration.
Inspection Record
TEVA Animal Health — FDA 483 Findings
Inspectors Ralph H. Vocque · Danial S. Hutchison · Patrick L. Wisor and 2 moreThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
3Training and personnel
Employees are not given training in the particular operations they perform as part of their function and written procedures required by current good manufacturing practice regulations.
4Process validation
(b) (4) The in-process control procedures were deficient in that it did not include an examination of tablet and capsule weight variation.
5Stability and storage
The written stability program for drug products does not include specific test metItods.
6Complaint and recall handling
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
7Laboratory and QC controls
Drug products failing to meet established standards, specifications, and quality control criteria are not rejected.
8Laboratory and QC controls
The reserve sample of drug product does not consist of at least twice the quantity necessary to perform all the required tests of drug product.
9Material and supplier control
There is a failure to thoroughly review 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.
10Other quality system
Determinations ofconformance to appropriate written specifications for acceptance are not made for drug products.
11Equipment and facility
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product.
12Laboratory and QC controls
The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established.
13Other quality system
for details ofdeficiencies noted.
14Process validation
Control procedures are not established which validate the performance ofthose manufacturing processes that may be responsible for causing variability in the characteristics ofin-process material and the drug product.
15Deviation, CAPA, and investigation
Deviations from written specifications are not justified.
16Equipment and facility
Adequate lighting is not provided in all areas.
17Deviation, CAPA, and investigation
for examples ofdeviations noted in investigations conducted by firm employees despite this training.
18Deviation, CAPA, and investigation
Investigations of an unexplained discrepancy did not extend to other batches of (b) (4) the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
19Deviation, CAPA, and investigation
(b) (4) Deviations from written production and process control procedures are not recorded and justified.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
