Glossary entry

English term or phrase:

fill Lot

English answer:

A registeration number for the filled lot/ lot to be filled

Added to glossary by Lingo Pros
Jun 22, 2006 04:16
18 yrs ago
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English term

fill Lot

English Medical Medical: Pharmaceuticals Contact Lens Care Product
COMPLETE﹫Upgrade C fill Lot E19670

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Change log

Jun 24, 2006 05:01: Lingo Pros changed "Field (specific)" from "Medical: Instruments" to "Medical: Pharmaceuticals"

Responses

2 days 34 mins
English term (edited): fill lot # X
Selected

A registeration number for the filled lot/ lot to be filled

COMPLETE:

A proprietary multi-purpose solution (by Allergan) for all soft contact lenses which has a built-in lubricant to help provide more comfortable lens wear. COMPLETE is also the fastest growing multi-purpose solution in the world, growing at a rate of nearly 3:1 over the competition.

Complete Upgrade C is an upgrade of the solution:

http://www.shareholder.com/AGN/downloads/2001AnnualReport.pd...

"Fill lot #" : (lot here means a parcel of articles offered as one item)

It's the registeration number of a "set number of units" of the prodoct in the stage in which the product shipment was "filled".

FDA:

The licensed manufacturer shall submit information about the
quantity of the product distributed under the product license,
including the quantity distributed to distributors. The interval
between distribution reports shall be 6 months. Upon written notice, FDA may require that the licensed manufacturer submit distribution reports under this section at times other than every 6 months.

The distribution report shall consist of the bulk lot number (from which the final container was filled), the fill lot numbers for the total number of dosage units of each strength or potency distributed (e.g., fifty thousand per 10-milliliter vials), the label lot number (if different from fill lot number), labeled date of expiration, number of doses in fill lot/label lot, date of release of fill lot/label lot for distribution at that time. If any significant amount of a fill lot/ label lot is returned, include this information.

http://google2.fda.gov/search?output=xml_no_dtd&oe=&lr=&prox...

http://www.fda.gov/foi/warning_letters/g4238d.htm
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