1Other quality system
In 1990, large plastic HDPE bins called “Mules” were introduced into the production operations.
Inspection Record
Time Cap Labs, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Returned goods were not identified as such.
3Other quality system
Recently manufactured batches of the ANDA product Nitroglycerin 2.5 mg ER Capsules has included the use of Wag (anti-static powder) in the capsule pellet blends.
4Deviation, CAPA, and investigation
The firm's SOPs do not address the need for conducting appropriate extended testing/ validation on batches subject to rework, formulation changes and /or significant manufacturing deviations.
5Regulatory reporting and change control
The firm has no change control SOP which describes the scope and procedure for the documentation, review and approval of changes in manufacturing .
6Other quality system
The firm has not established an acceptance range for the amount of timing solution used in the production of active stock pellets.
7Other quality system
The firm has no program for the periodic retesting of intermediate, active coated stock pellets (such as nitroglycerin stock pellets, chlorpheniramine maleate stock pellets, pheniramine maleate stock pellets etc.), and there is no established time limit for use of active pellets...
8Labeling and packaging
Stocks of finished product labeling were observed stored in the general quarantine warehouse, rather than being held within a restricted access area.
9Material and supplier control
Over the past 4 months, numerous batches of Aspirin E/C Tablets failed to meet the firm's in-process acid stage dis pbution testing, and various portions of these batches had to pf BALERS via the application of additional coating materials.
10Quality unit oversight
According to management, all batches of coated tablet products are visually inspected by QA after the final coating while in bulk carton storage.
11Stability and storage
As per the firm’s stability program, accelerated stability studies are conducted on products for reasons including formulation revisions and changes in methed of me-ufacture.
12Other quality system
Batch manufacturing instructions for active coated stock pellets are for the most part poorly defined and/or non-specific.
13Validation and qualification
The firm has no sop for the qualification of vendors and contract laboratories, nor has such documented qualification been conducted The firm has been using the services ofRenee: 3.
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.
