remediation of 483's and warning letters

Spanish translation: remediación / subsanación de los 483 y las cartas de advertencia

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:remediation of 483's and warning letters
Spanish translation:remediación / subsanación de los 483 y las cartas de advertencia
Entered by: Cristián Bianchi-Bruna

03:49 Apr 24, 2005
English to Spanish translations [PRO]
Medical: Health Care
English term or phrase: remediation of 483's and warning letters
Contexto: Food and Drug Administration.
Focus on remediation of 483's and Warning Letters exclusively.

Cómo traducirían remediation of 483's?
Valeria Vitale
Argentina
Local time: 18:22
remediación / subsanación de los 483 y las cartas de advertencia
Explanation:
Supongo que los 483 son formularios...
Selected response from:

Cristián Bianchi-Bruna
Costa Rica
Local time: 15:22
Grading comment
Muchas gracias a todos los que colaboraron.
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +2remediación / subsanación de los 483 y las cartas de advertencia
Cristián Bianchi-Bruna
5Just as a Fun-Fact ¶:^)
xxxOso


  

Answers


6 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
remediación / subsanación de los 483 y las cartas de advertencia


Explanation:
Supongo que los 483 son formularios...

Cristián Bianchi-Bruna
Costa Rica
Local time: 15:22
Works in field
Native speaker of: Native in EnglishEnglish, Native in SpanishSpanish
PRO pts in category: 4
Grading comment
Muchas gracias a todos los que colaboraron.

Peer comments on this answer (and responses from the answerer)
agree  xxxOso: Sí, el 483 es un formulario. ¶:^)
10 mins

agree  Otilia Acosta
1 hr
Login to enter a peer comment (or grade)

15 mins   confidence: Answerer confidence 5/5
Just as a Fun-Fact ¶:^)


Explanation:
Hola Valeria,
Sólo para apoyar la respuesta del colega Cristián, te paso estas definiciones:

"FDA 483
This is the form used by investigators to record their observations of non-compliance with cGMPs. While firms are not required to respond to 483's, it is considered prudent to do so, telling the FDA what will be done to correct not just the immediate, specific problem, but also the system(s) that are the root(s) of the problem. "

"Warning Letter
A Warning Letter is a communication to the firm that has been reviewed within several levels of the FDA, including the district office and the Center at FDA's headquarters. The Warning Letter generally states that the firm has made products that are adulterated, violating the Food, Drug, and Cosmetic Act and that the firm has a very limited amount of time to address the problem(s) before the FDA takes further regulatory action against the firm, the adulterated product, and responsible individuals. ..."

Buena suerte y saludos del Oso ¶:^)



    Reference: http://www.cgmp.com/fda483.htm
    Reference: http://www.cgmp.com/warningLetter.htm
xxxOso
Native speaker of: Native in SpanishSpanish
PRO pts in category: 92
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