Form 483 · FEI 1000260514
Form 483 issued July 27, 2018 · Jiutepec, Mexico
- Investigators
- Eae Michae A. Carles· Eee Mr Charles
- Observations
- 4
- Pages
- 3
- FEI number
- 1000260514
In short: On July 27, 2018, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Jiutepec, Morelos (FEI 1000260514). The investigators were Eae Michae A. Carles and Eee Mr Charles. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.48 (plumbing).
At a glance
Facilities & equipment and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate procedures designed to assure…
- 02
Water used in API operations (e.g., used for cleaning process equipment and in manufacturing) is not…
- 03
Procedures for receipt, identification, quarantine, sampling, testing-and approval of…
- 04
Cleaning validation and procedures do not include full establishment of process…
This inspection in context
Eae Michae A. Carles
1 document · 2018
Cites 211.122 (materials examination and usage criteria) more than any other section. Most of their documents are for sites in Mexico.
The firmSite 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 an FDA-inspected site?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and packaging & labeling. The most-cited regulation is 21 CFR 211.48 (plumbing). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Eae Michae A. Carles and Eee Mr Charles are named on this Form 483. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
This Form 483 is dated July 27, 2018.
How do I get the full Form 483 for an FDA-inspected site?
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.