Aldrich Chemical Company LLC
Form 483 issued December 13, 2021 · Miamisburg, Ohio
- Inspection
- Dec 10 – Dec 13, 2021
- Observations
- 5
- Pages
- 5
- FEI number
- 1000068559
In short: On December 13, 2021, FDA issued a Form 483 with 5 observations to Aldrich Chemical Company LLC in Miamisburg, Ohio (FEI 1000068559) after an inspection that ran Dec 10 – Dec 13, 2021. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations into discrepancies are not conducted thoroughly and…
- 02
Controls are not established to assure the authenticity, integrity and security of all computerized…
- 03
Written records of major laboratory…
- 04
LOYEE(S) Wh wl Environmental monitoring surface sample sites in GMP production areas…
This inspection in context
Questions about this 483
What did FDA find at Aldrich Chemical Company LLC?
FDA listed 5 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Aldrich Chemical Company LLC inspected by FDA?
The inspection ran Dec 10 – Dec 13, 2021, and the Form 483 is dated December 13, 2021.
How do I get the full Form 483 for Aldrich Chemical Company LLC?
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.