Avon Manufacturing (Guangzhou) Ltd.
Form 483 issued December 1, 2023 · Guangzhou, China
- Inspection
- Nov 27 – Dec 1, 2023
- Investigator
- Wayne D. McGrath
- Observations
- 4
- Pages
- 3
- FEI number
- 3002619387
In short: On December 1, 2023, FDA issued a Form 483 with 4 observations to Avon Manufacturing (Guangzhou) Ltd. in Guangzhou, China (FEI 3002619387) after an inspection that ran Nov 27 – Dec 1, 2023. The investigator was Wayne D. McGrath. Most observations concern quality system and facilities & equipment.
At a glance
3 of 4 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
The persons performing the cleaning and maintenance are not dating and signing or initialing the equipment…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Wayne D. McGrath
33 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAvon Manufacturing (Guangzhou) Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Avon Manufacturing (Guangzhou) Ltd.?
FDA listed 4 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Avon Manufacturing (Guangzhou) Ltd.?
Wayne D. McGrath is named on this Form 483, for the inspection of Nov 27 – Dec 1, 2023. Each investigator has a profile showing what they cite most.
When was Avon Manufacturing (Guangzhou) Ltd. inspected by FDA?
The inspection ran Nov 27 – Dec 1, 2023, and the Form 483 is dated December 1, 2023.
How do I get the full Form 483 for Avon Manufacturing (Guangzhou) Ltd.?
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.