Coastal Contract Packaging, Inc.
Form 483 issued March 17, 2023 · VENTURA, California
- Inspection
- Mar 13 – Mar 17, 2023
- Investigator
- Wenzheng Zhang
- Observations
- 7
- Pages
- 7
- FEI number
- 3004713804
In short: On March 17, 2023, FDA issued a Form 483 with 7 observations to Coastal Contract Packaging, Inc. in VENTURA, California (FEI 3004713804) after an inspection that ran Mar 13 – Mar 17, 2023. The investigator was Wenzheng Zhang. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
The quality control unit lacks authority to review production records to assure that no errors have…
- 03
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Wenzheng Zhang
8 documents · 2019–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmCoastal Contract Packaging, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Coastal Contract Packaging, Inc.?
FDA listed 7 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Coastal Contract Packaging, Inc.?
Wenzheng Zhang is named on this Form 483, for the inspection of Mar 13 – Mar 17, 2023. Each investigator has a profile showing what they cite most.
When was Coastal Contract Packaging, Inc. inspected by FDA?
The inspection ran Mar 13 – Mar 17, 2023, and the Form 483 is dated March 17, 2023.
How do I get the full Form 483 for Coastal Contract Packaging, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.