BRENNTAG PACIFIC, INC
Form 483 issued May 6, 2021 · Santa Fe Springs, California
- Inspection
- Apr 29 – May 6, 2021
- Investigator
- Dogbeda F. Mackenzie
- Observations
- 3
- Pages
- 3
- FEI number
- 3002820652
In short: On May 6, 2021, FDA issued a Form 483 with 3 observations to BRENNTAG PACIFIC, INC in Santa Fe Springs, California (FEI 3002820652) after an inspection that ran Apr 29 – May 6, 2021. The investigator was Dogbeda F. Mackenzie. Most observations concern quality system and production.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Dogbeda F. Mackenzie
14 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmBRENNTAG PACIFIC, INC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BRENNTAG PACIFIC, INC?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected BRENNTAG PACIFIC, INC?
Dogbeda F. Mackenzie is named on this Form 483, for the inspection of Apr 29 – May 6, 2021. Each investigator has a profile showing what they cite most.
When was BRENNTAG PACIFIC, INC inspected by FDA?
The inspection ran Apr 29 – May 6, 2021, and the Form 483 is dated May 6, 2021.
How do I get the full Form 483 for BRENNTAG PACIFIC, 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.