LABORATORIOS HAYMANN S.A.
Form 483 issued May 19, 2011 · MONTEVIDEO, Uruguay
- Inspection
- May 16 – May 19, 2011
- Investigator
- Ores Ernest F. Bizjak
- Observations
- 2
- Pages
- 1
- FEI number
- 3004000118
In short: On May 19, 2011, FDA issued a Form 483 with 2 observations to LABORATORIOS HAYMANN S.A. in MONTEVIDEO, MONTEVIDEO (FEI 3004000118) after an inspection that ran May 16 – May 19, 2011. The investigator was Ores Ernest F. Bizjak. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not followed for the cleaning and maintenance of equipment used in the manufacture…
- 02
At teas March NOMHor art was not added to…
This inspection in context
Ores Ernest F. Bizjak
1 document · 2011
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Uruguay.
The firmLABORATORIOS HAYMANN S.A. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LABORATORIOS HAYMANN S.A.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected LABORATORIOS HAYMANN S.A.?
Ores Ernest F. Bizjak is named on this Form 483, for the inspection of May 16 – May 19, 2011. Each investigator has a profile showing what they cite most.
When was LABORATORIOS HAYMANN S.A. inspected by FDA?
The inspection ran May 16 – May 19, 2011, and the Form 483 is dated May 19, 2011.
How do I get the full Form 483 for LABORATORIOS HAYMANN S.A.?
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.